A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as amitriptyline during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take amitriptyline, but in some cases, a doctor may decide that amitriptyline is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take amitriptyline or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking amitriptyline, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with amitriptyline. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: Web Site.

No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

WHY is this medicine prescribed?

Amitriptyline is used to treat symptoms of depression. Amitriptyline is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.

HOW should this medicine be used?

Amitriptyline comes as a tablet to take by mouth. It is usually taken one to four times a day. Take amitriptyline at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amitriptyline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of amitriptyline and gradually increase your dose.

It may take a few weeks or longer before you feel the full benefit of amitriptyline. Continue to take amitriptyline even if you feel well. Do not stop taking amitriptyline without talking to your doctor. If you suddenly stop taking amitriptyline, you may experience withdrawal symptoms such as nausea, headache, and lack of energy. Your doctor will probably decrease your dose gradually.

Are there OTHER USES for this medicine?

Amitriptyline is also used to treat eating disorders, post-herpetic neuralgia (the burning, stabbing pains, or aches that may last for months or years after a shingles infection), and to prevent migraine headaches. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking amitriptyline,

tell your doctor and pharmacist if you are allergic to amitriptyline or any other medications.

tell your doctor if you are taking cisapride (Propulsid) (not available in the U.S.) or monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have taken an MAO inhibitor during the past 14 days. Your doctor will probably tell you that you should not take amitriptyline.

tell your doctor if you have recently had a heart attack. Your doctor will probably tell you not to take amitriptyline.

tell your doctor if you drink large amounts of alcohol and if you have or have ever had glaucoma (an eye condition); an enlarged prostate (a male reproductive gland); difficulty urinating; seizures; an overactive thyroid gland (hyperthyroidism); diabetes; schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions); or liver, kidney, or heart disease.

tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking amitriptyline, call your doctor. Do not breast-feed while you are taking amitriptyline.

talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should not usually take amitriptyline because it is not as safe or effective as other medication(s) that can be used to treat the same condition.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking amitriptyline.

you should know that amitriptyline may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

remember that alcohol can add to the drowsiness caused by this medication.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Amitriptyline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

nausea

vomiting

drowsiness

weakness or tiredness

nightmares

headaches

dry mouth

constipation

difficulty urinating

blurred vision

pain, burning, or tingling in the hands or feet

changes in sex drive or ability

excessive sweating

changes in appetite or weight

confusion

unsteadiness

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

slow or difficult speech

dizziness or faintness

weakness or numbness of an arm or a leg

crushing chest pain

rapid, pounding, or irregular heartbeat

severe skin rash or hives

swelling of the face and tongue

yellowing of the skin or eyes

jaw, neck, and back muscle spasms

uncontrollable shaking of a part of the body

fainting

unusual bleeding or bruising

seizures

hallucinating (seeing things or hearing voices that do not exist)

Amitriptyline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

irregular heartbeat

seizures

coma (loss of consciousness for a period of time)

confusion

problems concentrating

hallucinating (seeing things or hearing voices that do not exist)

agitation

drowsiness

rigid muscles

vomiting

fever

cold body temperature

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to amitriptyline.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.